CLOBETASOL PROPIONATE- clobetasol propionate ointment usp, 0.05% ointment

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

Tersedia dari:

Encube Ethicals Private Limited

Rute administrasi :

TOPICAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to  suppress  the  hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Clobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Ringkasan produk:

Clobetasol Propionate Ointment USP, 0.05% is supplied in: 15 g tube (NDC 21922-017-04) 30 g tube (NDC 21922-017-05) 45 g tube (NDC 21922-017-06) 60 g tube (NDC 21922-017-07)  Store at controlled room temperature 15°-30°C (59°-86°F). DO NOT REFRIGERATE.   Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C1, Madkaim Ind. Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India.     Distributed by: Encube Ethicals Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713 USA Rev: 02 September 2019

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE OINTMENT USP,
0.05% OINTMENT
ENCUBE ETHICALS PRIVATE LIMITED
----------
CLOBETASOL PROPIONATE OINTMENT USP, 0.05%
RX ONLY
FOR TOPICAL DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
DESCRIPTION
Clobetasol propionate ointment USP contains the active compound
clobetasol
propionate, a synthetic corticosteroid, for topical dermatologic use.
Clobetasol, an
analog of prednisolone, has a high degree of glucocorticoid activity
and a slight degree
of mineralocorticoid activity.
Chemically, clobetasol propionate is (11β,
16β)-21-chloro-9-fluoro-11-hydroxy-16-
methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the
following
structural formula:
Clobetasol propionate has the empirical formula C
H
ClFO and a molecular weight of
467. It is a white to cream-colored crystalline powder insoluble in
water.
Clobetasol propionate ointment USP, 0.05% contains clobetasol
propionate 0.5 mg/g in a
base of propylene glycol, sorbitan sesquioleate, and white petrolatum.
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CLINICAL PHARMACOLOGY
Like other topical corticosteroids, clobetasol propionate has
anti-inflammatory,
antipruritic, and vasoconstrictive properties. The mechanism of the
anti-inflammatory
activity of the topical steroids, in general, is unclear. However,
corticosteroids are
thought to act by the induction of phospholipase A inhibitory
proteins, collectively called
lipocortins. It is postulated that these proteins control the
biosynthesis of potent
mediators of inflammation such as prostaglandins and leukotrienes by
inhibiting the
release of their common precursor, arachidonic acid. Arachidonic acid
is released
frommembrane phospholipids by phospholipase A .
PHARMACOKINETICS : The extent of percutaneous absorption of topical
corticosteroids
is determined by many factors, including the vehicle and the integrity
of the epidermal
barrier. Occlusive dressing with hydrocortisone for up to 24 hours has
not been
demonstrated to increase penetration; however, occlusion of
hydrocortisone for 96